Treatment of Osteoporosis - TOP1 Clinical Study

Osteoporosis Clinical Trial

— TOP1  

Official title:

Treatment of Osteoporosis by Panaceo: Randomized, Double-blind, Controlled, Study Assessed Effect on Bone Mineral Density and Bone Turnover of Panaceo Compared to Placebo in Osteoporotic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901989
• Other study ID #: TOP 001-2013
• Status: Completed
• Phase: N/A
• Start date: January 14, 2015
• Est. completion date: March 20, 2017

Study information

• Verified date: April 2019
• Source: Polyclinic K-center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates the effect of zeolite on bone mineral metabolism. The clinical parameters include bone mineral density, bone remodelling markers, fractures and fallings, the subjective evaluation of the overall health status and intensity of the musculoskeletal pain measured by VAS.

Description:

Randomized, placebo-controlled, double-blind study. The Study lasts 12 months. Study Population: The study population will consist of 100 patients with osteoporosis defined according BMD (bone mineral density) criteria: T score -2, 5 on the femoral neck, and, or T -2, 5 on L1-L5, who has not been treated before, or in whom privies treatment did not been successful, despite a gender or age. Subjects will be randomized in each cohort to receive PMA-zeolite (Panaceo) or placebo (1:1). All of them will receive Vit D3 800 j daily.

The double blind design can be reached by a "third party blinding" where a qualified person, not being involved in the assessment of the study, will administer the study treatment.

Follow up DXA, Ca, P, ALP, Osteocalcin, Cross laps, Creatinin will be done to each subject before the treatment, 6 months later and after 12 months. IVA (vertebral deformity assessment) will be performed before the treatment and after 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 100 subjects with osteoporosis Among those, as a subgroup, 20 subjects with diabetes type 2 and osteoporosis

• The osteoporosis- was diagnosed by standard DXA measurement (BMD T-score: - 2.5 or below )

Exclusion Criteria:

• chronic renal failure, secondary osteoporosis

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Device:
• zeolite
given for a period of 12 months
• cellulose
given for a period of 12 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Polyclinic K-center	University of Rijeka

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fractures and fallings	Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported	12 months
Other	Intensity of the musculoskeletal pain measured by VAS	the scale based on patient's subjective evaluation at the beginning and at the end of the study.	0-12 months
Other	Subjective evaluation of the overall health status and 6.	upon the end of the study in comparison to the beginning	0-12 months
Primary	Change of BMD (Bone mineral density)	BMD measurements are used to see how well osteoporosis treatments are working	0-6-12 months
Secondary	Cange of Bone remodelling marker Osteocalcin	Osteocalcin- parameter of the bone formation rate	0-6-12 months
Secondary	Cange of Bone remodelling marker Betacross laps	Betacross laps - parameter of the bone degradation rate	0-6-12 months